Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer

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Seagen

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Triple Negative Breast Neoplasms

Treatments

Drug: Pembrolizumab
Drug: ladiratuzumab vedotin

Study type

Interventional

Funder types

Industry

Identifiers

NCT03310957
MK-3475-721 (Other Identifier)
KEYNOTE 721 (Other Identifier)
SGNLVA-002
2017-002289-35 (EudraCT Number)

Details and patient eligibility

About

This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs. A side effect is anything the drugs do besides treating cancer. Pembrolizumab is a drug that can be used to treat triple-negative breast cancer. The trial will also find out if these drugs work to treat this type of cancer. Participants in this study have metastatic breast cancer. This means the cancer has spread to other parts of the body.

Full description

The primary goal of this study is to evaluate the combination of LV, which targets LIV-1- expressing tumor cells, with the checkpoint inhibitor pembrolizumab for patients with unresectable locally-advanced or metastatic triple-negative breast cancer. These two drugs act through distinct and possibly complementary modes of action. This is a single-arm, open-label, multicenter trial. Patients given LV and pembrolizumab during dose escalation will be monitored for frequency of dose-limiting toxicities to determine a recommended doses for expansion cohorts. In addition to safety measures, objective response rate, progression-free survival, overall survival, and other efficacy outcomes will be assessed.

Enrollment

186 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

* Metastatic or locally-advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) * Part D only: Tumor tissue PD-L1 Combined Positive Score \<10 expression. * Have not previously received cytotoxic therapy for the treatment of unresectable locally-advanced breast cancer or metastatic breast cancer * At least 6 months since prior treatment with curative intent and recurrence * At least 1 tumor 10mm in diameter or greater OR lymph node of at least 15 mm in short axis * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Able to provide biopsy tissue for biomarker analysis * Meet baseline laboratory data criteria

Exclusion criteria

* Prior immune-oncology therapy * Pre-existing neuropathy of at least Grade 2 * History of carcinomatous meningitis or active central nervous system (CNS) metastases. Patients are eligible if CNS metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 4 weeks prior to enrollment. Patients must be off corticosteroids. * Received prior radiotherapy within 2 weeks of start of study treatment or have not adequately recovered from prior radiotherapy * Active autoimmune disease requiring systemic treatment within the past 2 years * History of interstitial lung disease * Current pneumonitis or history of pneumonitis requiring steroids

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

186 participants in 1 patient group

LV + pembrolizumab
Experimental group
Description:
LV + pembrolizumab
Treatment:
Drug: ladiratuzumab vedotin
Drug: Pembrolizumab

Trial contacts and locations

50

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Central trial contact

Seagen Trial Information Support

Data sourced from clinicaltrials.gov

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